Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma (TREMENDOUS-2)

AstraZeneca

Status and phase

Enrolling

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Tremelimumab

Combination Product: Lenvatinib

Drug: Durvalumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT07081633

D419CL00025

Details and patient eligibility

About

This is a Phase II, single-arm, multicentre study, assessing the efficacy and safety of durvalumab and tremelimumab with lenvatinib in participants with unresectable HCC.

Enrollment

114 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings.
Must not have received prior systemic therapy for unresectable HCC.
Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
Child-Pugh Score class A.
ECOG performance status of 0 or 1 at enrollment.
At least 1 measurable lesion per RECSIT 1.1 guidelines

Exclusion criteria

Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy.
History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
Clinically meaningful ascites.
Patients with main portal vein thrombosis.
Active or prior documented GI bleeding.
Patient currently exhibits symptomatic or uncontrolled hypertension.
Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV)
Uncontrolled intercurrent illness